U.S. patent application number 10/588584 was filed with the patent office on 2009-02-26 for deployment device for cardiac surgery.
This patent application is currently assigned to CHILDREN'S MEDICAL CENTER CORPORATION. Invention is credited to Jeremy Cannon, Pedro del Nido, Franz Freudenthal, Yoshihiro Suematsu.
Application Number | 20090054975 10/588584 |
Document ID | / |
Family ID | 34860285 |
Filed Date | 2009-02-26 |
United States Patent
Application |
20090054975 |
Kind Code |
A1 |
del Nido; Pedro ; et
al. |
February 26, 2009 |
DEPLOYMENT DEVICE FOR CARDIAC SURGERY
Abstract
A deployment device for deploying a material into a patient,
said deployment device having a housing and a placement device
including a retracted condition within the housing for holding a
material, in a collapsed condition, within the housing and an
extended condition from the housing for disposing and releasing the
material at a predetermined site in an uncollapsed condition. A
method of deploying a material by placing the placement device in
an extended condition and affixing the material to the extended
placement device, retracting the placement device into the housing
with the material in a collapsed condition, extending the placement
device, and placing the material at a predetermined site in an
uncollapsed condition.
Inventors: |
del Nido; Pedro; (Boston,
MA) ; Suematsu; Yoshihiro; (Boston, MA) ;
Cannon; Jeremy; (Boston, MA) ; Freudenthal;
Franz; (La Paz, BO) |
Correspondence
Address: |
Kenneth I. Kohn;KOHN & ASSOCIATES
30500 Northwestern Highway, Suite 410
Farmington
MI
48334
US
|
Assignee: |
CHILDREN'S MEDICAL CENTER
CORPORATION
Boston
MA
|
Family ID: |
34860285 |
Appl. No.: |
10/588584 |
Filed: |
February 7, 2005 |
PCT Filed: |
February 7, 2005 |
PCT NO: |
PCT/US2005/003739 |
371 Date: |
November 4, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60542335 |
Feb 6, 2004 |
|
|
|
Current U.S.
Class: |
623/2.11 ;
623/23.72 |
Current CPC
Class: |
A61F 2/2481 20130101;
A61B 17/00234 20130101; A61F 2002/2484 20130101; A61B 2090/3614
20160201; A61B 17/0469 20130101; A61B 17/3468 20130101 |
Class at
Publication: |
623/2.11 ;
623/23.72 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61F 2/02 20060101 A61F002/02 |
Claims
1. A deployment device for deploying a material into a patient,
said deployment device comprising: a housing; and placement means
having a retracted condition within said housing for holding a
material, in a collapsed condition, within said housing and an
extended condition from said housing for disposing and releasing
the material at a predetermined site in an uncollapsed
condition.
2. The device according to claim 1, wherein said housing includes
an insertion end and an opposite end.
3. The device according to claim 2, wherein said housing includes a
lumen connecting said insertion end and said opposite end.
4. The device according to claim 3, wherein said placement means is
disposed in said insertion end of said housing and through said
lumen.
5. The device according to claim 1, wherein said placement means
includes controlling means for controlling the movement of said
device.
6. The device according to claim 5, wherein said controlling means
are finger loops.
7. The device according to claim 1, wherein said placement means
includes holding means for holding the material on the placement
means.
8. The device according to claim 7, wherein said holding means
include curvate, radially, outwardly extending arms.
9. The device according to claim 8, wherein said holding means
comprises an umbrella shaped wire.
10. The device according to claim 7, wherein said holding means
further includes spires attached to ends of said holding means,
said spires holding the material in place.
11. The device according to claim 1, wherein said placement means
includes a self-expanding ring.
12. The device according to claim 11, wherein said ring is formed
as a coiled loop.
13. The device according to claim 11, wherein said ring includes
gripping means for maintaining the material on said ring.
14. The device according to claim 13, wherein said gripping means
are sutures.
15. The device according to claim 14, wherein said sutures are
formed of a material selected from the group consisting essentially
of 8-0 prolene, 7-0 prolene, 4-0 nylon sutures.
16. The device according to claim 13, wherein said gripping means
is at least one wire.
17. The device according to claim 16, wherein said wire further
includes a needle for threading said wire through the material.
18. The device according to claim 17, wherein said wire is a thin
flexible wire.
19. The device according to claim 18, wherein said wire is formed
of a shape memory alloy.
20. The device according to claim 11, wherein said ring is formed
of a shape memory alloy.
21. The device according to claim 20, wherein said shape memory
alloy is selected from the group consisting essentially of nitinol
and elgiloy, copper-aluminum-nickel, copper-zinc-aluminum and
iron-manganese-silicon alloys.
22. The device according to claim 1, wherein said device is sized
to fit within a trocar.
23. A method of deploying a material into a patient by: actuating
the placement means of claim 1 to an extended condition and
affixing a material to the extended placement device; retracting
the placement device into the housing with the material in a
collapsed condition; inserting the deploying device into the body
of a patient; extending the placement device into the extended
condition in the body; and placing the material at a predetermined
site in the uncollapsed condition.
24. The method according to claim 23, wherein said inserting step
includes inserting the deployment device into a trocar placed
within the body.
25. The method according to claim 24, wherein said affixing step
includes threading a wire through the material to affix the
material to the extended placement device.
26. The method according to claim 25, further including the step of
removing the wire from the material after the material is placed at
the predetermined location.
27. A method of deploying a material into a patient by: inserting
the material, in a collapsed condition, in a cavity of a patient
through an opening made into the cavity; expanding the material
into an uncollapsed condition; and placing the material at a
predetermined site.
28. A method as set forth in claim 27, further including the step
of covering and patching over an opening in the cavity with the
uncollapsed material.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Technical Field
[0002] Generally, the present invention relates to a device for use
in cardiac surgery. More specifically, the present invention
relates to a deployment device for use in cardiac surgery.
[0003] 2. Description of the Related Art
[0004] Minimally invasive surgery has enabled physicians to carry
out numerous surgical procedures with less pain and disability than
conventional, open surgery. In performing minimally invasive
surgery, the surgeon makes a number of small incisions through the
body wall to obtain access to the tissues requiring treatment.
Typically, a trocar, which is a pointed, piercing device, is
delivered into the body with a cannula. After the trocar pierces
the abdominal or thoracic wall, it is removed and the cannula is
left with one end in the body cavity, where the operation is to
take place, and the other end opening to the outside. The cannula
typically has a small inside diameter, generally 3-10 millimeters.
A number of such cannulas can be inserted for any given
operation.
[0005] A viewing instrument, typically including a miniaturized
video camera, is inserted through one of these cannulas and a
variety of surgical instruments and retractors are inserted through
additional cannulas. The image provided by the viewing device may
be displayed on a video screen or television monitor, affording the
surgeon enhanced visual control over the instruments. Because a
commonly used viewing instrument is called an "endoscope," this
type of surgery is often referred to as "endoscopic surgery." In
the abdomen, endoscopic procedures are commonly referred to as
laparoscopic surgery, and in the chest, as thoracoscopic surgery.
Abdominal procedures may take place either inside the abdominal
cavity (in the intraperitoneal space) or in a space created behind
the abdominal cavity (in the retroperitoneal space). The
retroperitoneal space is particularly useful for operations on the
aorta and spine.
[0006] Minimally invasive surgery has virtually replaced open
surgical techniques for operations such as cholecystectomy and
anti-reflux surgery of the esophagus and stomach. Such minimally
invasive surgeries have not occurred in either peripheral vascular
surgery or cardiovascular surgery. An important type of vascular
surgery includes replacing or bypassing a diseased, occluded, or
injured artery. Arterial replacement or bypass grafting has been
performed for many years using open surgical techniques and a
variety of prosthetic grafts. These grafts are manufactured as
fabrics (often from Dacron or Teflon) or are prepared as autografts
(from the patient's own tissues) or heterografts (from the tissues
of animals). A graft can be joined to the involved artery in a
number of different positions, including end-to-end, end-to-side,
and side-to-side. This attachment between artery and graft is known
as an anastomosis. Constructing an arterial anastomosis is
technically challenging for a surgeon in open surgical procedures,
and is almost a technical impossibility using minimally invasive
techniques.
[0007] Minimally invasive surgery is of interest in cardiovascular
surgery because of the nature of the tissue of the heart. Cells
known as myocytes beat together in unison in a healthy heart when
ion channels open and close in an organized manner. Ions pass in
and out of the channels, and the change in concentration of ions
from within a cell to outside of a cell results in an electrical
potential, causing the cell itself to depolarize and repolarize.
The depolarization of one cell triggers the cell next to it to
depolarize, and thus a cascade effect of depolarization of all the
myocytes is triggered and the heart beats. Making several incisions
in cardiac tissue can interrupt this cascade during surgery and
change the beating of the heart. Keeping incisions to a minimum
with minimally invasive techniques enables beating heart surgery to
be successful while maintaining the electrical integrity of the
heart.
[0008] Many factors contribute to the difficulty of performing
arterial replacement or bypass grafting. See generally, Wylie,
Edwin J. et al., Manual of Vascular Surgery, (Springer-Verlag New
York), 1980. One such factor is that the tissues to be joined must
be precisely aligned with respect to each other to ensure the
integrity and patency of the anastomosis. If one of the tissues is
affixed too close to its edge, the suture can rip through the
tissue and impair both the tissue and the anastomosis. Another
factor is that, even after the tissues are properly aligned, it is
difficult and time consuming to pass the needle through the
tissues, form the knot in the suture material, and ensure that the
suture material does not become tangled. These difficulties are
exacerbated by the small size of the artery and graft. The arteries
subject to peripheral vascular and cardiovascular surgery typically
range in diameter from several millimeters to several centimeters.
A graft is typically about the same size as the artery to which it
is being attached, thus further complicating the procedure. Another
factor contributing to the difficulty of such procedures is the
limited time available to complete the procedure. The time to
complete an arterial replacement or bypass graft is limited because
there is no blood flowing through the artery while the procedure is
being done. If blood flow is not promptly restored, sometimes in as
little as thirty minutes, the tissue that the artery supplies blood
to may experience significant damage, or even death (tissue
necrosis). In addition, arterial replacement or bypass grafting is
made more difficult by the need to accurately place and space the
sutures to achieve a permanent hemostatic seal. Precise placement
and spacing of sutures is also required to achieve an anastomosis
with long-term patency.
[0009] Highly trained and experienced surgeons are able to perform
arterial replacement and bypass grafting in open surgery using
conventional sutures and suturing techniques. A suture includes a
suture needle that is attached or "swedged on" to a long, trailing
suture material. The needle must be precisely controlled and
accurately placed through both graft and artery. The trailing
suture material must be held with proper tension to keep the graft
and artery together, and must be carefully manipulated to prevent
the suture material from tangling. In open surgery, these maneuvers
can usually be accomplished within the necessary time frame, thus
avoiding the subsequent tissue damage (or tissue death) that can
result from prolonged occlusion of arterial blood flow.
[0010] The difficulty of suturing a graft to an artery using
minimally invasive surgical techniques has effectively prevented
the safe use of this technology in both peripheral vascular and
cardiovascular surgical procedures. In some minimally invasive
procedures, such as those in the abdominal cavity, the
retroperitoneal space, or chest, the space in which the operation
is performed is more limited. The exposure to the involved organs
is also more, restricted than with open surgery. Moreover, in a
minimally invasive procedure, the instruments used to assist with
the operation are passed into the surgical field through cannulas.
When manipulating instruments through cannulas, it is extremely
difficult to position tissues in their proper alignment with
respect to each other, pass a needle through the tissues, form a
knot in the suture material once the tissues are aligned, and
prevent the suture material from becoming tangled. Therefore,
although there have been isolated reports of vascular anastomoses
being formed by minimally invasive surgery, no system has been
provided for wide-spread surgical use which would allow such
procedures to be performed safely within the prescribed time
limits.
[0011] Recent advances in medical imagining technology coupled with
advances in computer-based image processing and modeling
capabilities have given physicians an unprecedented ability to
visualize anatomical structures in live patients, and to use this
information in diagnosis and treatment planning. The precision of
image-based pre-surgical planning often greatly exceeds the
precision of actual surgical execution. Precise surgical execution
has been limited to procedures, such as brain biopsies, in which a
suitable stereotactic frame is available. The inconvenience and
restricted applicability of such a frame or device has led many
researchers to explore the use of robotic devices to augment a
surgeon's ability to perform geometrically precise tasks planned
from computed tomography (CT) or other image data. The ultimate
goal of the research is a partnership between man (the surgeon) and
machines (computers and robots) that seeks to exploit the
capabilities of both in order to better perform the task than can
be accomplished alone by either man or machine.
[0012] Machines are very precise and untiring and can be equipped
with any number of sensory feedback devices. Numerically controlled
robots can move a surgical instrument through an exactly defined
trajectory with precisely controlled forces. On the other hand,
surgeons are very dexterous. They are also quite strong, fast, and
are highly trained to exploit a variety of tactile, visual, and
other cues. "Judgmentally" controlled, a surgeon understands
surgical techniques and uses dexterity, senses, and experience to
execute the procedure. However, the surgeon usually wants to be in
control of everything that goes on. If the surgeon is interested in
increasing his precision within acceptable limits of time or with
sufficient speed, the surgeon must be willing to rely on machines
to provide the precision.
[0013] Such less invasive attempts for positioning bypass grafts at
target vessel locations have used small ports to access the
anatomy. These approaches use endoscopic visualization and modified
surgical instruments (e.g. clamps, scissors, scalpels, etc.) to
position and suture the ends of the bypass graft at the host vessel
locations. Attempts to eliminate the need for cardiopulmonary
bypass support while performing CABG procedures have benefited from
devices that stabilize the motion of the heart, retractors that
temporarily occlude blood flow through the host vessel, and shunts
that re-route the blood flow around the anastomosis site.
Stabilizers and retractors still require significant time and
complexity to expose the host vessel and suture the bypass graft to
the host vessel wall. Shunts not only add to the complexity and
length of the procedure, but they require a secondary procedure to
close the insertion sites proximal and distal to the anastomosis
site.
[0014] Attempts to automate the formation of sutureless anastomoses
have culminated into mechanical stapling devices. Mechanical
stapling devices have been disclosed for creating end-end
anastomoses between the open ends of transected vessels. The
Berggren et al. patents disclose an automatic stapling device for
use in microsurgery (see, e.g., U.S. Pat. Nos. 4,607,637,
4,624,257, 4,917,090, and 4,917,091). The stapling device includes
mating sections containing pins that are locked together after the
vessel ends are fed through lumens in the sections and everted over
the pins. The stapling device maintains intima-to-intima apposition
for the severed vessel ends but has a large profile and requires
impaling the everted vessel wall with the pins.
[0015] U.S. Pat. No. 4,214,587 to Sakura describes a mechanical
end-end stapling device designed to reattach severed vessels. The
device has a wire wound into a zigzag pattern to permit radial
motion and contains pins bonded to the wire that are used to
penetrate tissue. One vessel end is everted over and secured to the
pins of the end-end stapling device, and the other vessel end is
advanced over the end-end stapling device and attached with the
pins.
[0016] Another mechanical end-end device that inserts mating pieces
into each open end of a severed vessel is disclosed in U.S. Pat.
No. 5,503,635 to Sauer et al. Once positioned, the mating pieces
snap together to bond the vessel ends. The end-end devices are
amenable to reattaching severed vessels but are not suitable to
producing end-end anastomoses between a bypass graft and an intact
vessel, especially when exposure to the vessel is limited.
[0017] Mechanical stapling devices have also been disclosed for
end-side anastomoses. The devices are generally designed to insert
bypass grafts, which can be attached to the mechanical devices,
into the host vessel through a large incision and secure the bypass
graft to the host vessel. The Kaster patents describe vascular
stapling apparatus for producing end-side anastomoses. (See U.S.
Pat. Nos. 4,366,819, 4,368,736, and 5,234,447.) The end-side
apparatus is inserted through a large incision in the host vessel
wall. The apparatus has an inner flange that is placed against the
interior of the vessel wall, and a locking ring that is affixed to
the fitting and contains spikes that penetrate into the vessel
thereby securing the apparatus to the vessel wall. The bypass graft
is itself secured to the apparatus in the everted or non-everted
position through the use of spikes incorporated in the apparatus
design.
[0018] U.S. Surgical has developed automatic clip appliers that
replace suture stitches with clips (see, e.g., U.S. Pat. Nos.
5,868,761, 5,868,759, and 5,779,718). The clipping devices have
been demonstrated to reduce the time required to produce the
anastomosis but still require creating a large incision through the
host vessel wall. As a result, blood flow through the host vessel
must be interrupted while creating the anastomosis.
[0019] U.S. Pat. No. 5,695,504 to Gifford et al. discloses an
end-side stapling device that secures harvested vessels to host
vessel walls while maintaining intima-to-intima apposition. The
stapling device is also inserted through a large incision in the
host vessel wall and uses staples incorporated in the device to
penetrate into tissue and secure the bypass graft to the host
vessel.
[0020] The Walsh et al. patents disclose a similar end-side
stapling device. (See U.S. Pat. Nos. 4,657,019, 4,787,386, and
4,917,087.) The end-side device has a ring with tissue piercing
pins. The bypass graft is everted over the ring; the pins then
penetrate the bypass graft thereby securing the bypass graft to the
ring. The ring is inserted through a large incision created in the
host vessel wall and the tissue piercing pins are used to puncture
the host vessel wall. A clip is then used to prevent dislodgment of
the ring relative to the host vessel.
[0021] End-side stapling devices require insertion through a large
incision, which dictates that blood flow through the host vessel
must be interrupted during the process. Even though these and other
clipping and stapling end-side anastomotic devices have been
designed to decrease the time required to create the anastomosis,
interruption of blood flow through the host vessel increases the
morbidity and mortality of bypass grafting procedures, especially
during beating heart CABG procedures. A recent experimental study
of the U.S. Surgical ONE-SHOT anastomotic clip applier observed
abrupt ventricular fibrillation during four of fourteen internal
thoracic artery to left anterior descending artery anastomoses in
part due to coronary occlusion times exceeding 90 seconds (Heijmen
et al: "A Novel One-Shot Anastomotic Stapler Prototype for Coronary
Bypass Grafting on the Beating Heart: Feasibility in the Pig" J
Thorac Cardiovasc Surg. 117:117-25; 1999). It would therefore be
useful to develop a device for inserting a suitable patch into
cardiac or other tissue that overcomes the above problems.
SUMMARY OF THE INVENTION
[0022] According to the present invention, there is provided a
deployment device for deploying a material into a patient, said
deployment device including a housing and a placement device. The
placement device includes a retracted condition within the housing
for holding a material in a collapsed condition within the housing
and an extended condition from the housing for disposing and
releasing the material at a predetermined site in an uncollapsed
condition. A method of deploying a material includes the steps of
actuating the placement device to the extended condition and
affixing the material to the extended placement device, retracting
the placement device into the housing with the material in a
collapsed condition, extending the placement device, and placing
the material at a predetermined site in an uncollapsed
condition.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Other advantages of the present invention are readily
appreciated as the same becomes better understood by reference to
the following detailed description when considered in connection
with the accompanying drawings wherein:
[0024] FIGS. 1A and B are side views of one embodiment of a
deployment device of the present invention;
[0025] FIG. 2 is a side view partially cut away of the deployment
device of the present invention contained within a housing;
[0026] FIGS. 3A and B are side views showing a tube system for
affixing material to an alternative embodiment of a deployment
device, FIG. 3B is an enlarged view of the tube system shown in
FIG. 3A;
[0027] FIGS. 4A and B are side views showing a band system for
affixing material to the deployment device, FIG. 4B is an enlarged
view of the band system shown in FIG. 4A;
[0028] FIGS. 5A and B are side views showing a wire system for
affixing material to the deployment device, FIG. 5B is an enlarged
view of the wire system shown in FIG. 5A;
[0029] FIGS. 6 A through D are enlarged views of the attachment
devices used to attached material to the deployment device;
[0030] FIGS. 7A through C are side and enlarged views of the wire
system for affixing material to the deployment device, and sutures
from the ring that can be used to attach the patch to the ring
deployment system with the same release mechanism;
[0031] FIGS. 8A and B are enlarged side views of the wire system
for affixing material to the deployment device;
[0032] FIG. 9 is a side view of material affixed to the deployment
device of the present invention;
[0033] FIG. 10 is a top view of material affixed to the deployment
device of the present invention;
[0034] FIG. 11 is a plan view of the deployment device as a ring
with a suture for affixing implantable material to the ring;
[0035] FIG. 12 is a plan view of the deployment device as a ring
with a suture for affixing implantable material to the ring, where
the suture is partially removed;
[0036] FIG. 13 is a plan view of the deployment device as a ring
with a suture for affixing implantable material to the ring, where
the suture is partially removed; and
[0037] FIG. 14 is a side view of the deployment device wherein the
device is shaped as a spatula.
DESCRIPTION OF THE INVENTION
[0038] Generally, the present invention provides a deployment
device for deploying bioprosthetic or synthetic materials or
analogous body tissue into a body of a patient.
[0039] More specifically, the deployment device 10 of the present
invention includes a housing or cannula 12 and an insertion device
14. The housing 12 and insertion device 14 are connected such that
the insertion device 14 is disposed within a lumen 16 of the
housing 12. Preferably, the housing 12 and insertion device 14 are
formed of two separate pieces of material.
[0040] The lumen 16 of the housing 12 includes two ends, an
insertion end 16 for inserting into the body of the patient and an
opposite end 18 in which the insertion device 14 is disposed. The
housing 12 of the present invention is preferably formed in a
manner known to those of skill in the art using a resilient
material, such as 304 or 316 stainless steel. While steel is the
preferred material, any resilient material that can be formed
containing the structures disclosed herein can be used.
[0041] The interior of the lumen 16 is hollow thus enabling the
insertion device 14 to be disposed within the lumen 16. The lumen
16 is large enough to contain a bioprosthesis or patch. Further,
the lumen 16 can be in any shape that is capable of holding therein
the material. For example, the lumen 16 can be cylindrical, square,
rectangular, oval, or triangular.
[0042] The insertion device 14 of the present invention includes a
handle 22 for controlling the insertion device 14. The handle 22
can be in any form that is capable of being attached to the
insertion device 14 of the present invention as long as the handle
22 provides the surgeon with the ability to retract or extend the
insertion device 14 and material being held by the insertion device
14. For example, the handle 22 can includes at least two, and
preferably three loops 24, 26, 28 that are sized to allow the
insertion of fingers therein. The loops 24, 26, 28 are sized to
enable the surgeon to insert two or three fingers into the loops
24, 26, 28. The loops 24, 26, 28 are preferably made of a resilient
material that is not malleable and therefore cannot be easily bent
during use. Examples of such materials include, but are not limited
to, hard plastics and solid metals, such as steel.
[0043] The loops 24, 26, 28 are arranged, as shown in the figures,
via a t-bar 30, which is a t-shaped portion of the device. The
t-bar 30 is configured such that one of the loops 24, 26, 28 is
located at three 32, 34, 36 of the four ends of the t-bar 30. The
t-bar 30 is formed of a resilient, non-malleable material.
Preferably, the t-bar 30 is formed of the same material that is
used in making the loops 24, 26, 28. On the fourth end 38 of the
t-bar 30 there is located a retractable rod 40.
[0044] The rod 40 is disposed within the lumen 16 of the housing 12
and extends from the fourth end 38 of the t-bar 30 to the insertion
end 20 of the housing 12. The rod 40 is formed of a resilient
material that does not bend easily. Examples of such materials are
well known to those of skill in the art. The end of the rod 40 that
exits the insertion end 20 includes multiple material holding
devices 42. The holding devices 42 are formed of resilient, but
pliable material, such that the holding devices 42 can extend
outward in a curved umbrella shape, as shown in the figures, or can
be held in a straight position, i.e. when the rod 40 is retracted
into the lumen 16 of the housing 12. There are preferably six to
eight holding devices 42.
[0045] The holding devices 42 are shown in the form of curvate,
radially outwardly extending spokes when in the extended condition.
They easily conform to the inner shape of the lumen 16 when
retracted therein.
[0046] On the ends of the holding devices 42 are spires 44. Spires
are devices that are able to hold and subsequently release the
material to be inserted into the body in place without damaging the
material. Preferably, the spires are formed as a barb.
[0047] Alternatively, the holding device 42 can be formed as a ring
42'. The ring 42' can be formed of a resilient self-expanding,
self-contracting material, such materials are well known to those
of skill in the art. The ring 42' is preferably formed of a
memory-type material or spring-like material that conforms to the
shape of the lumen but can expand when extended outside of the
lumen 16. The ring 42' can be formed of any resilient
self-expanding, self-contracting material, including, but not
limited to, nitinol, elgiloy, and other shape-memory metals. The
shape memory metal can be formed of any suitable, biocompatible
shape memory metal known to those of skill in the art. Examples of
shape memory metals that can be used include, but are not limited
to, nickel-titanium alloy, generically known as nitinol, elgiloy,
copper-aluminum-nickel, copper-zinc-aluminum and
iron-manganese-silicon alloys. Preferably, the shape memory metal
material is made of nitinol. Nitinol has two phases, a martensitic
phase and an austenitic phase. A ring 42' of nitinol can be formed
to a desired shape such as that shown in FIG. 3. The shape is heat
set into position. The nitinol is then cooled while maintaining its
shape. The shape can be plastically deformed to a new shape. Upon
subsequent heating, the metal returns to the original shape. There
are no limitations on the size, diameter, thickness, or shape of
the ring 42'.
[0048] The shape memory material is secured to the rod 40 by
crimping a portion 46 of a shape memory ring 42' over the end of
the rod 40 that exits the insertion end 20. The ring 42' is then
secured, such as by gluing. Alternatively, the shape memory ring
42' can be secured to the rod 40 using other methods known to those
of skill in the art for affixing shape memory alloys to other
materials.
[0049] The ring 42' also includes a gripping device 48. The
gripping device 48 can include any material capable of holding and
maintaining the material on the ring 42' without adversely altering
the shape memory material of the ring 42'. One example of such a
gripping device is a suture. The suture is constructed from a
biocompatible material. The sutures can be monofilaments or
multifilaments (e.g. braided). Suitable materials include, but are
not limited to, polypropylene, Dacron.TM., polyester, Gortex.TM.,
nylon, 7-0 prolene, 8-0 prolene, and 4-0 nylon. Commercial examples
include Ethibond Excel.TM. polyester fiber sutures, Ethilon.TM.
nylon sutures, Mersilene.TM. polyester fiber sutures, Nurolon nylon
sutures, and Prolene polypropylene sutures, each available from
Ethicon. The material of the gripping device 48 can be
bioresorbable or non-bioresorbable (e.g. substantially permanent).
As used herein, absorbable filament means a sterile strand prepared
from a substance (e.g. collagen) derived healthy mammals or a
synthetic polymer. Bioresorbable filaments can be constructed from
materials of biological origin (e.g. surgical gut) and are
digestable by tissue enzymes. Alternatively, a bioabsorbable
filament can be constructed from a synthetic polymer that can be
broken down by hydrolysis or a shape memory polymer. The absorbable
filament can be treated or constructed to modify its resistance to
absorption. The filament that forms the gripping device 48 can also
include an antimicrobial agent. The gripping device 48 can also be
formed as a band, tube, or piece of mesh as shown in FIGS. 3
through 6.
[0050] Alternatively, the holding device 42 can be formed as a
spatula 42''. The spatula 42'' can be formed of a resilient
self-expanding, self-contracting material, such materials are well
known to those of skill in the art. The spatula 42'' is preferably
formed of a memory-type material or spring-like material that
conforms to the shape of the lumen but can expand when extended
outside of the lumen 16. The spatula 42'' can be formed of any
resilient self-expanding, self-contracting material, including, but
not limited to, nitinol, elgiloy, and other shape-memory metals.
The shape memory metal can be formed of any suitable, biocompatible
shape memory metal known to those of skill in the art. Examples of
shape memory metals that can be used include, but are not limited
to, nickel-titanium alloy, generically known as nitinol, elgiloy,
copper-aluminum-nickel, copper-zinc-aluminum and
iron-manganese-silicon alloys. Preferably, the shape memory metal
material is made of nitinol. Nitinol has two phases, a martensitic
phase and an austenitic phase. A spatula 42'' of nitinol can be
formed to a desired shape such as that shown in FIG. 14. The shape
is heat set into position. The nitinol is then cooled while
maintaining its shape. The shape can be plastically deformed to a
new shape. Upon subsequent heating, the metal returns to the
original shape. There are no limitations on the size, diameter,
thickness, or shape of the spatula 42''.
[0051] The shape memory material is secured to the rod 40 by
crimping a portion 46 of a shape memory spatula 42'' over the end
of the rod 40 that exits the insertion end 20. The spatula 42'' is
then secured, such as by gluing. Alternatively, the shape memory
spatula 42'' can be secured to the rod 40 using other methods known
to those of skill in the art for affixing shape memory alloys to
other materials.
[0052] The spatula 42'' also includes a gripping device 48. The
gripping device 48 can include any material capable of holding and
maintaining the material on the spatula 42'' without adversely
altering the shape memory material of the spatula 42''. One example
of such a gripping device is a suture. The suture is constructed
from a biocompatible material. The sutures can be monofilaments or
multifilaments (e.g. braided). Suitable materials include, but are
not limited to, polypropylene, Dacron.TM., polyester, Gortex.TM.,
nylon, 7-0 prolene, 8-0 prolene, and 4-0 nylon. Commercial examples
include Ethibond Excel.TM. polyester fiber sutures, Ethilon.TM.
nylon sutures, Mersilene.TM. polyester fiber sutures, Nurolon nylon
sutures, and Prolene polypropylene sutures, each available from
Ethicon. The material of the gripping device 48 can be
bioresorbable or non-bioresorbable (e.g. substantially permanent).
As used herein, absorbable filament means a sterile strand prepared
from a substance (e.g. collagen) derived healthy mammals or a
synthetic polymer. Bioresorbable filaments can be constructed from
materials of biological origin (e.g. surgical gut) and are
digestable by tissue enzymes. Alternatively, a bioabsorbable
filament can be constructed from a synthetic polymer that can be
broken down by hydrolysis or a shape memory polymer. The absorbable
filament can be treated or constructed to modify its resistance to
absorption. The filament that forms the gripping device 48 can also
include an antimicrobial agent.
[0053] The deployment device 10 of the present invention can be
used with a trocar for the introduction of a bioprosthetic or
synthetic material, such as a patch. Examples of bioprosthetics
include, but are not limited to, autologous pericardium, a
collapsed valve, a baffle, or other prosthetic reinforcement.
[0054] The deploying device 10 functions as follows. The insertion
device 22 is actuated to the extended condition. When the insertion
device is extended, the holding devices 42 extend radially
outwardly and away from each other. The shape of the radial
extension depends upon the requirements of the materials being
affixed thereto. A material to be placed within the body of a
patient is placed on the spires 44 of the holding devices 42 of the
insertion device 22. The rod 40 is then retracted into the lumen 16
of the housing 12, thereby collapsing the material within the
housing 12. The deployment device 10 can then either be inserted
into a trocar, inserted directly into a body, or placed at a
predetermined site that requires the attached material. Once the
deployment device 10 is inserted into the trocar, or other
location, the insertion device 14 is depressed, thereby extending
the rod 40 outside of the trocar and into the body of the patient.
When the material is placed in the proper location, then the
material can be released by the spires 44 and affixed in the proper
location in an uncollapsed condition.
[0055] Alternatively, when a ring 42' or spatula 42'' is used as
the holding device 42, the device 10 functions as follows. The
insertion device 22 is actuated to the extended condition. When the
insertion device is extended, the ring 42' or spatula 42'' expands.
The shape of the expansion depends upon the requirements of the
materials being affixed thereto. A material to be placed within the
body of a patient is placed on the gripping device 48 of the ring
42' or spatula 42'' of the insertion device 22. When the gripping
device 48 is a suture, the suture is sewn through the perimeter 50
of the material. Such affixing can occur either by hand or
automatically. The ring 42' or spatula 42'' is then retracted
enabling the rod 40 to be retracted into the lumen 16 of the
housing 12, thereby collapsing the material within the housing 12.
The deployment device 10 can then either be inserted into a trocar,
inserted directly into a body, or placed at a predetermined site
that requires the attached material. Once the deployment device 10
is inserted into the trocar, or other location, the insertion
device 14 is depressed, thereby extending the rod 40 outside of the
trocar and into the body of the patient. When the material is
placed in the proper location, then the material can be released by
the gripping device 48 and affixed in the proper location in an
uncollapsed condition. When the gripping device 48 is a suture, the
ends of the suture 52, which extend through the lumen 16 of the
housing 12 are pulled thereby withdrawing the suture from the
material. Preferably, prior to removing the suture, staples or
other fixing devices are used to affix the material in place within
the patient.
[0056] For example, autologous pericardium or a 0.1 mm
polytetrafluoroethylene (PTFE) patch (Gore-Tex, W. L. Gore &
Associates, Inc, Flagstaff, Ariz.) can be trimmed and then sutured
along the ring 42' with 8-0 prolene (Ethicon Inc., Somerville,
N.J.). The device 10 can be delivered through a trocar (5 mm in
diameter), and the ring 42', with autologous pericardium, can be
extended out of the trocar and allowed to expand.
[0057] An example of when the present invention can be used is
during closed heart cardiac surgery. During closed heart cardiac
surgery there are times when a patch is needed in a vessel or on
the inner wall of the chamber of the heart. The present invention
can be used to dispose such a patch, in situ, without need of
by-pass open-heart surgery. The patch can be delivered, disposed,
and released using the present invention.
[0058] Throughout this application, author and year, and patents,
by number, reference various publications, including United States
patents. Full citations for the publications are listed below. The
disclosures of these publications and patents, in their entireties
are hereby incorporated by reference into this application in order
to more fully describe the state of the art to which this invention
pertains.
[0059] The invention has been described in an illustrative manner,
and it is to be understood that the terminology that has been used
is intended to be in the nature of words of description rather than
of limitation.
[0060] Obviously, many, modifications and variations of the present
invention are possible in light of the above teachings. It is,
therefore, to be understood that within the scope of the described
invention, the invention may be practiced otherwise than as
specifically described.
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